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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diiodohydroxyquinoline
EC Number:
201-497-9
EC Name:
Diiodohydroxyquinoline
Cas Number:
83-73-8
Molecular formula:
C9H5I2NO
IUPAC Name:
5,7-diiodoquinolin-8-ol
Details on test material:
- Name of test material: diiodohydroxyquinoline
- Molecular formula: C9H5I2NO
- Molecular weight: 396.95
- Substance type: organic
- Physical state: solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg±200g
No. of animals : Three
Acclimatization :The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
Environmental conditions : Air conditioned rooms with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
The 0.5 gm of test compound was applied on a small area (approximately 6 cm2) of intact skin site. The test compound was moistened with distilled water prior to application. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The treated animals were then housed individually and plastic collar was put around their necks in order to prevent access by the animal to the patch and resultant ingestion of the test product. After patch removal, the dressing and unabsorbed test product was removed and the site of application was cleaned with lukewarm water.
Duration of treatment / exposure:
14 days
Observation period:
The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application.
Number of animals:
No. of animals : Three
Details on study design:
Two healthy rabbit of body weight 1.80kg±200gm selected for study after acclimatization. The test compound in the amount of 0.5 gm was applied uniformly at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment.
After 4 hours the patch was removed and the skin reactions were graded according to Draize’s method.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0
Reversibility:
no data

Any other information on results incl. tables

INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

 

Rabbit No.

Sex

INTACT SKIN

3 Min.

4 Hours

24 Hours

48 Hours

72 Hours

14 days

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

01

F

0

0

0

0

0

0

0

0

0

0

0

0

02

F

-

-

0

0

0

0

0

0

0

0

0

0

03

F

-

-

0

0

0

0

0

0

0

0

0

0

Total

0

0

0

0

0

0

0

0

0

0

0

0

Mean

0

0

0

0

0

0

0

0

0

0

0

0

Grand Total

0.00

 

Dermal Irritation Index: 0.0/4 = 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Primary dermal irritation index of diiodohydroxyquinoline was calculated as 0.00 From this result it can be concluded that the test compound diiodohydroxyquinoline is not irritant to skin at the tested dose level of 0.5 gm in New Zealand white rabbits under test condition.
Executive summary:

The Primary dermal irritation index ofdiiodohydroxyquinoline was calculated as 0.00 From this result it can be concluded that the test compound diiodohydroxyquinoline is not irritant to skin at the tested dose level of 0.5 gm in New Zealand white rabbits under test condition.